Associate Director – Analytical Development

Job not on LinkedIn

🕒 July 30

🇺🇸 United States – Remote

💵 $185k - $215k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 34%

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CultureHQ

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

☁️ SaaS

SaaS

CultureHQ is a web-based application; the provided text only indicates that the application requires JavaScript to run. No additional information about the company's offerings, target customers, or industry was provided.

📋 Description

• Lead analytical activities across Cogent’s development portfolio and commercial product • Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, methods, and other CMC technical documentation • Review analytical data packages supporting release testing, stability studies, drug substance, intermediates, and drug product manufacturing activities • Partner with Regulatory CMC, Quality, and external CDMOs to ensure timely delivery of analytical documentation and reports • Support analytical method development, validation, qualification, transfer, and lifecycle management activities • Author, review, and manage analytical methods, validation protocols and reports, specifications, trend reports, and regulatory submission documentation • Coordinate analytical reporting for drug substance and drug product stability programs • Support preparation and review of CMC sections for regulatory submissions, health authority responses, and other regulatory filings • Participate in investigations related to deviations, OOS, OOT, and laboratory events • Collaborate with external laboratories and CDMOs to ensure analytical deliverables are scientifically sound, compliant, and aligned with program timelines • Drive continuous improvement in analytical reporting processes, data integrity, document quality, and operational efficiency • Provide technical leadership in reviewing, interpreting, and communicating analytical results

🎯 Requirements

• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 8+ years of relevant industry experience, OR Master's degree with 10+ years of experience, OR Bachelor's degree with 12+ years of experience • Experience in analytical development, analytical reporting, CMC technical writing, or related pharmaceutical development functions • Strong understanding of small molecule analytical development, method validation, method transfer, stability testing, specifications, and control strategies • Demonstrated experience authoring, reviewing, and approving technical documents including analytical methods, protocols, reports, and regulatory-supporting documentation • Experience reviewing analytical data generated by CDMOs, CROs, and external testing laboratories • Working knowledge of HPLC/UPLC, GC, dissolution, spectroscopy, mass spectrometry, wet chemistry, particle size analysis, and related pharmaceutical characterization methods • Familiarity with ICH, FDA, EMA, and other global regulatory requirements related to analytical development and CMC documentation • Strong scientific writing, data interpretation, problem-solving, and project management skills • Excellent verbal and written communication skills with the ability to effectively communicate complex technical information to diverse audiences • Proven ability to work effectively within a cross-functional matrix organization and build strong relationships with internal stakeholders and external partners • Highly organized with the ability to manage multiple priorities in a fast-paced biotech environment • Preferred: Experience supporting late-stage development or commercial programs • Preferred: Experience contributing to IND, NDA, MAA, or other global regulatory submissions

🏖️ Benefits

• Competitive salary • Target bonus of 20% • Ongoing stock awards • 100% coverage of medical, dental, and vision premiums for employees and their families • Funding of up to 75% of in-network deductibles • 401(k) match with immediate vesting • Generous paid time off • 12 weeks of fully paid parental leave • Paid family and medical leave for all employees regardless of location • Company-paid short-term disability coverage for up to 20 weeks • Wellness programs • Tuition reimbursement • Inclusive family-forming support